Colorado recalls

Sold nationwide. ConvaTec's Esteem Body Soft Convex Urostomy Pouches may leak from the cap during normal use. This affects multiple model numbers distributed nationwide across the U.S. No injuries have been reported to date.

Moderate·FDA·Aug 26, 2026·ConvaTec

Sold nationwide. Fort Defiance Industries is recalling its Automated Field Steam Sterilizer because the 120V connector on the water recovery system may intermittently lose its ground connection. This could make the electrical fault current path unreliable. No injuries have been reported.

Moderate·FDA·Aug 26, 2026·Fort Defiance Industries

Sold nationwide. Medtronic is recalling three MiniMed insulin pump models (640G, 670G, and 780G) that were loaned out and may have been cleaned with products that are incompatible with the pump. This could damage the case or keypad, let moisture in, and cause the pump to deliver too much or too little insulin. No injuries have been reported. The recall covers 280 affected pumps and was distributed in several European countries.

Moderate·FDA·Aug 26, 2026·Medtronic3 products

Sold nationwide. BMC Medical Co., Ltd. is reporting retroactive rework that was conducted on Luna G3 APAP devices at the 3B/React Health warehouse in 2024. This retroactive reporting involves approximately 20,160 units with specific serial numbers.

Serious·FDA·Aug 26, 2026·BMC Medical

Sold nationwide. Boston Scientific is recalling two ENROUTE Transcarotid Neuroprotection System products: the standard system (Material Number SR-200-NPS) and the Plus system (SR-250-NPS). The recall covers about 164,700 units, distributed in the US and to Australia, Canada, China and Jamaica. The arterial sheath tip may separate, fully or partially, during use. No injuries have been reported.

Serious·FDA·Aug 26, 2026·Boston Scientific2 products

Sold nationwide. Siemens is recalling two quinidine assay kits, the Syva EMIT 2000 and the Beckman Coulter Emit 2000, because certain lots may give falsely high quinidine measurements. Quinidine is a heart and antimalarial drug, so inaccurate results could lead to inappropriate treatment. The recall covers 75 units total and was distributed in California and Italy.

Serious·FDA·Aug 26, 2026·Siemens2 products

Sold nationwide. Beckman Coulter is recalling two products, DxC 500i and DxC 500 AU clinical analyzer modules, when they run software version 1.5 or lower. When a new Parameter Package is imported into an instrument that already has one, custom calculated test rules can silently revert to default settings, which may produce incorrect patient test results without an error message. New installations are not affected, and no injuries have been reported.

Moderate·FDA·Aug 26, 2026·Beckman Coulter2 products

Sold nationwide. Paragon 28 is recalling two custom-made navicular cage foot implants because their oxygen level is above the allowed limit. Elevated oxygen may reduce the metal's ductility, meaning it may be less able to bend before breaking. The devices were distributed across the US, and no injuries have been reported.

Moderate·FDA·Aug 26, 2026·Paragon 282 products

Sold nationwide. Gentherm Medical is recalling three thermal regulating system models, Blanketrol II Model 222S, Innercool Coolblue Console Model STx, and Blanketrol III Model 233, because the 115V CPU board can overheat and cause the device to shut down. The recall covers about 9,940 units distributed in the US nationwide, Puerto Rico, and several other countries. No injuries have been reported.

Moderate·FDA·Aug 26, 2026·Gentherm Medical3 products

Sold nationwide. A firmware defect in the KidneyVault datalogger may cause it to lose its configuration, resulting in a blank screen and inability to display organ preservation parameters. This affects 1,445 systems distributed across the US. No injuries have been reported.

Moderate·FDA·Aug 26, 2026·Paragonix

Sold nationwide. Certain lots of the Siemens Immulite 2000 Syphilis Screen diagnostic assay may incorrectly report low-level positive results as negative. This means some patients with syphilis could receive a false negative result, delaying diagnosis and treatment.

Serious·FDA·Aug 26, 2026·Siemens2 products

Sold nationwide. Halyard LAVH PACK surgical kits (Model USAR053-11) containing Clearify Visualization System components were sterilized using ethylene oxide (EO) in a way that did not follow manufacturer instructions. This improper sterilization may have caused a kit component to leak.

Moderate·FDA·Aug 26, 2026·AVID Medical

Sold nationwide. Getinge's Maquet Critical Care AB recalled nine Y Sensor modules (Model 6693662) for SERVO-U and SERVO-N ventilator systems. The modules did not complete electrical safety and functional tests during production. They were distributed to facilities in California, Georgia, Minnesota, and New York, and no injuries have been reported.

Moderate·FDA·Aug 26, 2026·Maquet

Sold nationwide. Boston Scientific is recalling two Suture Cinch endoscopic tissue approximation devices, the OverStitch Suture Cinch and the Suture Cinch Long. The devices may fail to deploy the cinch implant or fail to cut the suture as intended. The recall covers 60,654 units of each product, distributed in the US and many other countries. No injuries have been reported.

Moderate·FDA·Aug 26, 2026·Boston Scientific2 products

Sold nationwide. Tobii Dynavox is recalling two TD Navio speech generating devices: the TD Navio Midi (model 1000798) and the TD Navio Maxi (model 1000799). Under certain conditions, the battery mounting tabs can become damaged, letting the battery move inside the device and possibly causing an internal short circuit, localized heating, and gas venting. No injuries have been reported.

Moderate·FDA·Aug 26, 2026·Tobii Dynavox2 products

Sold nationwide. Arrowhead DE LLC is recalling certain Arrow-LOK implants used to fix bones in the lesser toes after corrective surgery. The implants did not complete a required gamma radiation dose audit, which could reduce their sterility and potentially lead to patient infection. No injuries have been reported.

Moderate·FDA·Aug 26, 2026·Arrowhead

Sold nationwide. The ARVIS Surgical Navigation System Gen 2, a computer-controlled device used by surgeons to help position orthopedic implants during knee, hip, and shoulder surgery, has a sensor issue that can cause the image displayed through the eyepiece to appear tilted. This misalignment could affect the accuracy of surgical guidance if the surgeon relies solely on the displayed image without cross-checking with other alignment methods.

Moderate·FDA·Aug 26, 2026·Kico

Sold nationwide. The Philips Cardiac Workstation 5000 (Product Number 860439) can intermittently display inaccurate native heart rate data. This may affect the reliability of heart rate measurements used in clinical decision-making. The issue has been identified in approximately 796 units distributed worldwide.

Moderate·FDA·Aug 26, 2026·Philips2 products

Dentsply Sirona and SDI Limited are recalling about 1,444 Capsule Mixers, Model No. 5546068, with serial numbers in the 0003-1533 range. The units can release an electrical discharge when they are unplugged. The notice reports no injuries.

Moderate·FDA·Aug 26, 2026·SDI

Sold nationwide. Intersurgical is recalling two sizes of its One-Piece Guedel Airway, a device used to keep a patient's airway open. The devices could be blocked or partly blocked, and about 22,844 units are affected. They were distributed nationwide, with US distribution in CT, FL, IN, MI, OH, and VA, and no injuries have been reported.

Moderate·FDA·Aug 26, 2026·Intersurgical2 products

Sold nationwide. Foundation Medicine's Protocol Configuration Tool (PCT) v2.0.0, used with Hamilton Microlab STAR liquid handlers to conduct F1CDx and F1LCDx tests, has a software issue that can cause the application to close unexpectedly. This affects 32 units distributed in Massachusetts and North Carolina.

Moderate·FDA·Aug 26, 2026·Foundation Medicine

Sold nationwide. The EndoFLIP endoscopic measuring system has a 24-hour usage limit that causes catheters to be incorrectly marked as expired. This prevents catheters from being used in clinical procedures even though they may still be suitable for use.

Moderate·FDA·Aug 26, 2026·Covidien

Sold nationwide. Spectral Instruments is recalling 75 units across two products: 40 Lago X and 35 Ami HTX. The on-screen "X-Ray On" banner can briefly be absent during the run readiness check. No injuries have been reported.

Moderate·FDA·Aug 26, 2026·Spectral Instruments2 products

BD Needle Kits used for emergency intraosseous (IO) access may have an obturator (the needle's internal plunger) that locks to the needle hub and becomes difficult or impossible to remove after placement. This locking is caused by out-of-tolerance manufacturing dimensions. If the obturator cannot be removed, a new needle may need to be placed, potentially delaying treatment.

Serious·FDA·Aug 26, 2026·Bard

Sold nationwide. Coast Citrus Distributors is recalling bulk jalapeno peppers packaged between July 1–31, 2026, due to potential Salmonella Javiana contamination. The peppers were distributed in bulk containers to wholesale distributors across the central and eastern United States, with further nationwide distribution for food processing. No retail packages or consumer illnesses have been identified.

Serious·FDA·Aug 26, 2026·Coast Tropical

Prospector Popcorn is recalling four gourmet popcorn flavors: Chocolate Mocha, Maple Walnut Ice Cream, Fudge Brownie, and Belgian Chocolate Toffee, in 1.5 oz and 3.5 oz sizes. The nutrition labels understate carbohydrate and cholesterol amounts. No illnesses or injuries have been reported.

Moderate·FDA·Aug 26, 2026·Prospector Popcorn4 products

Sold nationwide. American Regent is recalling 12 injectable and oral solution products, including nitroglycerin, cyanocobalamin (vitamin B12), aminocaproic acid, atropine, acetylcysteine, selenious acid, papaverine, niCARdipine, and the trace element products Multrys and Tralement. Some vials may contain particulate matter identified as hair, glass, and/or paraformaldehyde. No injuries have been reported.

Moderate·FDA·Aug 26, 2026·American Regent12 products

Sold nationwide. Some Fresenius Kabi morphine sulfate prefilled syringes are labeled as morphine 2 mg/mL but actually contain Dilaudid (hydromorphone) 0.5 mg/0.5 mL. This labeling error could lead to patients receiving the wrong medication and dose. The affected lot is 6402820 with an expiration date of 12/2028.

Serious·FDA·Aug 26, 2026·Fresenius Kabi

Sold nationwide. Mylan Pharmaceuticals is recalling one lot of Acamprosate Calcium 333 mg delayed-release tablets because they failed to meet dissolution specifications—meaning the tablets may not break down and release the medication as intended in the body. This could result in ineffective treatment. No injuries have been reported.

Moderate·FDA·Aug 26, 2026·Mylan

Sold nationwide. Golden State Medical Supply is recalling Carbamazepine Tablets, USP 200mg due to black specks found in some tablets. This is a manufacturing quality issue. The affected lots were distributed nationwide.

Moderate·FDA·Aug 26, 2026·Golden State Medical Supply